Effect of Maraviroc on Endothelial Function in HIV-Infected Patients
The purpose of this study is to determine the potentially beneficial aspects of CCR5 inhibition on inflammation and endothelial function as measured by brachial artery reactivity in antiretroviral treated HIV patients with an undetectable viral load.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
- Percent Change in FMD [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]endothelial function as assessed by measured flow-mediated vasodilation (FMD) of the brachial artery
|Study Start Date:||January 2010|
|Estimated Study Completion Date:||June 2014|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Maraviroc
For subjects assigned to the maraviroc group, subjects will receive maraviroc at 300mg by mouth twice daily for 24 weeks in addition to taking their current anti-HIV medication. For subjects on ritonavir, the dose of maraviroc will be 150mg by mouth twice daily.
For subjects assigned to the maraviroc group, they will receive maraviroc at 300mg by mouth twice daily for 24 weeks in addition to taking their current anti-HIV medications. For subjects on ritonavir, the dose will be reduced to 150mg by mouth twice daily for 24 weeks.
|Placebo Comparator: Placebo||
For subjects assigned to the placebo group, they will receive a matching placebo pill 300mg to be taken by mouth twice daily for 24 weeks in addition to taking their current anti-HIV medications.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00844519
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94110|